Methods and compositions for animal feed

ABSTRACT

The present invention is directed to methods and compositions that are useful in producing, feeding and growing animals. Compositions of the present invention comprise an extracted mineral element composition as disclosed herein. Animal lifespan and production is improved when provided with compositions comprising an extracted mineral element composition.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 14/790,798, filed Jul. 2, 2015, which is acontinuation of U.S. patent application Ser. No. 13/239,290 filed Sep.21, 2011, now U.S. Pat. No. 9,180,141; which claims the priority of U.S.Provisional Application No. 61/385,064, filed Sep. 21, 2010, both ofwhich are incorporated herein by reference in their entirety.

TECHNICAL FIELD

The present invention is directed to compositions and methods forimproved meat and egg production, and improved animal feed supplements.Particularly, the invention comprises providing an extracted mineralelement composition to animals, birds, fish, reptiles, livestock andpets.

BACKGROUND OF THE INVENTION

Animals are essential for human life. Besides the pleasurable aspectsderived from living and working with animals and observing wildlife,animals are a major food source for humans and may also be used toprovide wearable articles. For mass consumption, animals are generallyraised in large scale production facilities, in contrast to farmingpractices in past times where animals were raised in smaller farmingoperations. Large scale production facilities with their attendantcrowding of animals, increased infection control, and stressfullifestyle for the animals, require more human control of the animals'environment and diet.

An example of large scale production of animal husbandry is productionof poultry. Poultry production comprises two major categories, meatproduction and egg production. Poultry production encompasses a numberof different species, including chickens reared for laying eggs (i.e.,“layers”) and chickens reared for meat production (i.e., “broilers”),turkeys, ducks, and other waterfowl and game birds. The particular typeof production may differ for each species though aspects are common toall.

Eggs are typically collected from breeder farms, taken to a hatchery andstored from 0 to 10 days prior to being set in an incubator. When theeggs are placed in incubators, embryonic development begins. Differentspecies of birds require different incubation times. Chickens hatch in21 days while turkeys and ducks need 28 days. Artificial incubationallows for the hatching of large numbers of chicks of the same age. Eggsare set in specially designed trays that allow the eggs to be tilted andturned. Eggs are transferred from setting trays into hatching trays 3days before expected hatch. The hatchlings (chicks, poults, orducklings) are processed (vaccinated, gender sorted, and/or otherprocedures) then transported to commercial grow-out facilities.

Chickens are specifically bred to have characteristics that aredesirable in the final product. Meat poultry is selected for good meattype, fast growth, disease resistance, and efficient conversion of feedto meat. The body weights of meat and egg production strains aregenerally quite different. Meat production birds, i.e., broilers, arerelatively easy to raise. When the birds arrive, they are placed intobrooder rings around a heater (brooder) and introduced to waterers andfeed. Generally, broilers are brooded in a portion of the house until acertain age before being given access to the entire barn.

Some farms separate male and female birds, a practice calledseparate-sex feeding. When birds are separated and fed according togender (versus rearing males and females together), there will be moreuniformity among males and among females in the flock. Separation of thebirds also allows producers to feed diets that more closely meet thenutritional needs of the male and female birds.

Raising turkeys takes more time than raising broilers, as turkeys takelonger to mature. Generally, a turkey is sent to market anywhere between15 and 25 weeks of age. At 20 weeks of age, a male turkey should weighabout 35-40 pounds. The duck is a rapidly growing animal. A typical duckwill weigh 7 pounds in only 6 or 7 weeks.

Different strains of chickens are used for table egg production. Theseare selected for high egg production, large egg size, and small bodyweight for better conversion of feed to eggs and good livability. Themodern laying hen begins laying eggs at approximately 18 weeks of ageand by the end of her first year, she may have produced upwards of 200eggs—nearly 25 pounds. The hen reaches peak egg production (e.g., >95%or 95⁺%) within 4 to 6 weeks after she begins to lay eggs.

Poultry diets generally consist of common grains and protein sourceswith mineral and vitamin supplements. Animal or vegetable fats may beadded to increase energy and reduce dustiness. Corn, grain sorghum,wheat, oats, and barley are often used for poultry feeding in the UnitedStates. Soybean meal is widely used as a protein supplement. Otherimportant protein supplements are meat meal, fish meal, safflower meal,feather meal, and canola meal.

What is needed are food and/or water supplements or additives that canincrease the meat production or egg laying capacity, enhance the overallhealth of the animals and lower the costs of raising poultry. Suchmethods and compositions would be advantageous for other livestock oranimals.

SUMMARY

The present invention comprises methods and compositions for productionof meat, milk and eggs. The methods and compositions are beneficial forall animals, whether companion animals, working animals or livestockanimals. Examples are provided herein for poultry production, though theinvention contemplates use in other animals.

The present invention comprises methods and compositions for increasedsurvival rate of young animals. For example, methods and compositionscomprise providing an extracted mineral element composition as taughtherein to baby chicks to increase survival rate of the baby chicks.

The present invention comprises methods and compositions for increasedgrowth rate of animals. For example, methods and compositions compriseproviding an extracted mineral element composition as taught herein tochickens to increase growth rates. Chickens treated by such methods withsuch compositions reach harvest weight more quickly. For example, afterfive weeks of providing an extracted mineral element composition withfeed and/or water, or separately alongside feed or water, the chickens,on average, weighed five pounds, which is an increase in weight comparedto chickens not fed an extracted mineral element composition.

The present invention comprises methods and compositions for increasingthe useful production time period and the lifespan of an animal. Forexample, methods and compositions comprise providing an extractedmineral element composition as taught herein to laying hens to increasethe number of months and/or years that the hens lay eggs. Typically,laying hens are removed from production every year. For example, afterfeeding laying hens an extracted mineral element composition of thepresent invention, hens that were three years old were continuing to layeggs.

The present invention comprises methods and compositions for improvedegg production. For example, methods and compositions comprise providingan extracted mineral element composition as taught herein to laying hensfor eggs with a firmer shell. Eggs with a firmer shell are less apt tobreak in shipping, thus resulting in a higher yield of eggs better ableto survive handling during shipping and receipt.

The present invention comprises methods and compositions for increasingthe hatch rate of poultry. For example, methods and compositionscomprise providing an extracted mineral element composition as taughtherein to breeder chickens for increased hatch rates. Additionally,chicks born from such breeder chickens are stronger and a larger numberof the hatch group survive.

The present invention comprises methods and compositions for improvingfeed conversion. For example, methods and compositions compriseproviding an extracted mineral element composition as taught herein topoultry for increased feed conversion.

The present invention comprises methods and compositions for reducing orpreventing infection. For example, methods and compositions compriseproviding an extracted mineral element composition as taught herein topoultry for reducing or preventing infection in poultry.

Methods and compositions of the present invention comprise providing anextracted mineral element composition in feed and/or water provided tothe animals, or in a composition separate from feed or water. Anextracted mineral element composition may be provided with continuouslyavailable feed or water, or may be provided at specific time points orfor long or short durations.

DESCRIPTION OF THE FIGURES

FIGS. 1A and 1B show quantitative data for vaccinated and non-vaccinatedchickens across several weeks for chickens on water. FIGS. 1C and 1Dshow quantitative data for vaccinated and non-vaccinated chickens acrossseveral weeks for chickens on extracted mineral element composition inwater.

FIG. 2 shows the average body weight over several weeks for chickens onwater and for chickens on extracted mineral element composition inwater.

FIG. 3 shows the average breast circumference over several weeks forchickens on water and for chickens on extracted mineral elementcomposition in water.

FIG. 4 shows the average thigh circumference over several weeks forchickens on water and for chickens on extracted mineral elementcomposition in water.

FIG. 5 shows the comparison of percent differences in the body weightsover several weeks for chickens on water and for chickens on extractedmineral element composition in water.

FIG. 6 shows the comparison of percent differences in the breastcircumferences over several weeks for chickens on water and for chickenson extracted mineral element composition in water.

FIG. 7 shows the comparison of percent differences in the thighcircumferences over several weeks for chickens on water and for chickenson extracted mineral element composition in water.

FIG. 8 shows the average dressed weights over several weeks for chickenson water and for chickens on extracted mineral element composition inwater.

FIG. 9 shows the mortality rates of vaccinated and non-vaccinatedchickens for chickens on water and for chickens on extracted mineralelement composition in water.

FIG. 10 shows the percent mortality rate of chickens on water and forchickens on extracted mineral element composition in water.

FIG. 11 shows a soil extraction process.

DETAILED DESCRIPTION

The present invention comprises methods and compositions for productionof meat, milk and eggs. The present invention comprises methods andcompositions for nutritional enrichment of foodstuffs such as, but notlimited to, pork, beef, poultry and the like and comprises use of feedor water supplements formulated for feeding to animals at predeterminedstages of growth or at all stages of growth. Whilst the supplement andformulae of the present invention are suitable as feed for producingbeef, milk, pigs, goats, sheep, lamb, fish, poultry, including meat andeggs, and enhancing the health of household pets, rodents, monkeys, zooanimals, reptiles, and other living organisms under human control, theinvention will mainly be described with reference to its application inraising poultry. The term poultry is generally used for all sort ofbreeds of domesticated birds independent of their age, comprisingchickens, ducks, geese, fowl, pigeons, turkeys, and ostriches.

Methods and compositions of the present invention comprise providingfeed or water comprising an extracted mineral element composition tolivestock. Methods and compositions of the present invention compriseproviding a composition comprising an extracted mineral elementcomposition in addition to and separate from water or feed provided tolivestock. Compositions comprising an extracted mineral elementcomposition are formulated for systemic administration, such as oraladministration, to poultry, e.g., via feed or water. The feed or watercompositions, or a composition comprising an extracted mineral elementcomposition separate from the feed or water, can be formulated alongwith customary excipients that are physiologically well-tolerated bybirds in suitable forms such as capsules, powders, liquids, emulsionssuch as oil-in-water and water-in-oil, and suspensions, or an extractedmineral element composition may be provided in the form of a poultryfeed supplement, poultry feed or provided in water compositions, or inliquid form in addition to water. The quantity of the mineralcompositions are provided in terms of ppm in feed or water and can varydepending on the age of the animal, use and bird species. The presentinvention contemplates feed in forms known to those skilled inlivestock, e.g., poultry, production and includes, but is not limitedto, forms of feed, such as in pellets, chips and the like.

An aspect of the present invention comprises feed supplements forpoultry in commercial poultry facilities. An example of use ofcompositions comprising an extracted mineral element composition inbreeder chickens is herein provided, but is in no way a limitation ofthe invention. Compositions comprising an extracted mineral elementcomposition may be used in methods including, but not limited toproviding breeder chickens, egg laying chickens and meat productionchickens, and all other types of poultry and other animals.

A primary objective of a poultry breeder operation is to produce fertileeggs that will be hatched to produce chicks for broiler operations andfuture breeder operations. Any reduction in rate of egg productionand/or egg fertility, due to physiological or environmental impacts, canreduce operation efficiency and increase costs. Typically, egg fertilityis equated to the percentage of eggs that hatch into viable chicks.Methods of the present invention comprise increasing hatch rate or eggfertility by providing to breeder chickens, in feed or watercompositions, or in separate supplementation compositions, compositionscomprising an extracted mineral element composition. Increase of hatchrate is determined by measuring the hatch rate for birds that do notreceive an extracted mineral element composition compared to those birdsthat receive an extracted mineral element composition.

Animal husbandry of poultry breeder birds is typically carried out intwo stages. The first is a development stage during which the chicks aregrown into “pullets”. Breeder bird chicks are grown for a period of 22to 24 weeks in communal pens. Birds are fed a diet formulated to promotelongevity and control weight gain of both males and females. Methods ofthe present invention comprise increasing the survival rate of chicks byproviding to the chicks a feed or drink composition, or a separatecomposition, such compositions comprising an extracted mineral elementcomposition. At the conclusion of this stage of development, the pulletsare ready for the next stage.

The pullets are transferred to breeder houses for the remainder of theirlives. Birds are typically maintained in the breeder house for 30 to 35weeks. Females and males are placed separately into the houses. Methodsof the present invention comprise feeding pullets by providing to thepullets a feed or drink composition, or a separate composition, suchcompositions comprising an extracted mineral element composition. A goalof breeder operations is to achieve good mating and egg laying behaviorsof mature birds. Methods of the present invention comprise increasingmating and egg laying behaviors of mature birds by providing to thebirds a feed or drink composition, or a separate composition, suchcompositions comprising an extracted mineral element composition. Newlyplaced female pullets come into egg laying maturity after 5 to 6 weeksin the breeder house environment. In traditional breeder operations,when females come into egg laying maturity, the females frequent nestingboxes. Each female can lay 1 to 3 eggs per day. Egg production per birdpeaks at 10 to 12 weeks after placement and slowly declines thereafter.Eggs are laid in the nest boxes or on the floor and must be collecteddaily. Reduction in mating behavior ultimately reduces egg fertility.The breeder house manager monitors egg fertility often, typicallyweekly. Reduced egg fertility results in removal of non-mating maleswith replacement by fresh male pullets, called spiking, in order torestore normal mating behavior throughout the house. Methods of thepresent invention comprise decreasing the need for spiking by providingthe birds a feed or drink composition, or a separate composition, suchcompositions comprising an extracted mineral element composition.Methods of the present invention comprise prolonging the egg fertilityof birds by providing to the birds a feed or drink composition, or aseparate composition, such compositions comprising an extracted mineralelement composition.

The present invention provides methods and compositions that positivelyimpact bird health with the use of an extracted mineral elementcomposition. This includes a diet supplement or additive for poultry forpoultry feed or water comprising an extracted mineral elementcomposition. Incorporation of an extracted mineral element compositioninto bird rations improves bird health due to improvements incardiovascular health and feed conversion. For example, the red color ofmale bird's combs and wattles is a general indicator of good birdhealth. Birds in physiological decline often show a purple comb/wattlecolor. Bird house managers often change diet formulations and dailyrations in response to observation of purple comb/wattle color.Incorporation of an extracted mineral element composition into birddiets applies to both male and female birds and is useful for reducingmortality of aged birds. Specifically, an extracted mineral elementcomposition supplemented diet improves male bird health for improvingmating behavior over a longer period of time, and reduces the need to“spike” males during a breeder cycle.

In general, feed or water comprising an extracted mineral elementcomposition impacts breeder bird performance in multiple ways. Theseinclude improvement of cardiovascular health and feed conversion;reduced rate of infection; reduced mortality of males and females;improved longevity of male mating behavior; reduced need to spike males;and improved egg laying productivity of females. Feed or water additiveor supplement compositions of the present invention are advantageous tobird health in positively impacting mortality or related bird healthissues. Poultry can experience cardiovascular difficulties, leading tobird death or poor mating performance or egg production and weight.

Feed or water compositions comprising an extracted mineral elementcomposition, or a separate supplement composition comprising anextracted mineral element composition according to the present inventioncan provide advantageous feed conversion results while maintaining birdweight characteristics. Bird weight is determined by body weightmeasurement, typically done by measuring the weight of each bird. Feedperformance data for feed or water comprising an extracted mineralelement composition, or a separate composition comprising an extractedmineral element composition, according to the present invention exhibitimproved feed conversion values and improved adjusted feed conversionvalues, wherein the average adjusted feed conversion value is defined asa ratio of a total feed consumption for the poultry over a time periodto a total weight gain of the poultry over the time period after removalof a weight of any poultry that died during the time period.

The present invention comprises compositions and methods for increasingthe live weight of poultry. Methods and compositions of the presentinvention comprise providing compositions comprising an extractedmineral element composition and methods for treating animals withcompositions comprising an extracted mineral element composition toincrease growth and weight gain. Compositions and methods for increasingthe live weight of poultry are convenient and economical to administer.Compositions and methods for increasing the live weight of poultry areeasy and economical to manufacture.

For example, the present invention comprises a livestock feed or watercomposition comprising an extracted mineral element composition forinclusion in the diet of livestock, at any time prior to slaughter, forthe production of meat or eggs for human consumption, the feed or watercomposition comprising an extracted mineral element composition asdisclosed herein. Feeding comprises any time up to and includingimmediately prior to slaughter of the livestock for meat produce. Alivestock feed or water composition may comprise from 0.001% to 100% ofthe total dietary intake of the animal.

The present invention comprises a method of feeding livestock or poultryprior to slaughter of the livestock or poultry for production of meatfor human consumption, the method comprising, a) preparing or providingan animal feed or water composition comprising an effective amount of anextracted mineral element composition for inclusion in the diet oflivestock or poultry, and b) feeding the livestock or poultry with thefeed or water composition comprising an extracted mineral elementcomposition up to and immediately prior to slaughter, such as at or fora particular time period or continuously.

The present invention comprises a method of feeding livestock or poultryprior to slaughter of the livestock or poultry for production ofnon-fertilized eggs for human consumption or for fertilized eggs forbreeder purposes, the method comprising, a) preparing or providing ananimal feed or water composition comprising an extracted mineral elementcomposition for inclusion in the diet of livestock or poultry, and b)feeding the livestock with the feed or water composition comprising aneffective amount of an extracted mineral element composition up to andimmediately prior to slaughter, such as at or for a particular timeperiod or continuously.

A particular time period may comprise a growth period for the animals, aspan of time of confinement for the animals, or may be a regular orirregular time period in which the composition is provided. Continuouslymay comprise every day for every feeding or watering period, or maycomprise all or some of a particular feeding or watering schedule, suchas every evening or every morning, or alternating patterns of evening ormorning. The methods may comprise providing a composition that isseparate from the feed or water that comprises an extracted mineralelement composition. Such a separate composition comprising an extractedmineral element composition may be provided at the same time that feedor water is provided or at times different from when feed or water isprovided.

The present invention comprises a method of feeding livestock or poultryusing an extracted mineral element composition, for inclusion in thediet of livestock or poultry for the production of meat for humanconsumption, the method comprising providing an extracted mineralelement composition in feed or water compositions, or in a compositionseparate from feed or water, to livestock, and allowing the livestock toeat or drink the extracted mineral element composition. The feed orwater comprising an extracted mineral element composition may comprise0.001% to 100% of the dietary intake of the livestock or poultry. Thepresent invention comprises a method of feeding livestock or poultrycomprising providing or administering an effective amount of anextracted mineral element composition for inclusion in the diet oflivestock or poultry for the production of fertilized eggs for breederproduction or unfertilized eggs for human consumption, the methodcomprising providing an effective amount of an extracted mineral elementcomposition in feed or water compositions, or in a composition separatefrom feed or water, to livestock or poultry, and allowing the livestockor poultry to eat or drink the extracted mineral element composition.

The present invention comprises methods for making feed compositionscomprising an extracted mineral element composition. An extractedmineral element composition may be added to standard feed compositionsas are generally used for a particular animal, including age and sexspecific feeds, resulting in a supplemented feed. An extracted mineralelement composition may be added during the mixing of ingredients of thefeed at a feed mill, and the extracted mineral element composition maybe provided in a dry, liquid or steam form. An extracted mineral elementcomposition may be added to pre-formed feed pellets or chips in a dry orliquid form as a finishing step prior to packaging the feed, or at anyother desired step in making the feed. An extracted mineral elementcomposition may be added to the feed by the poultry producer at one ormore of the large scale production facilities before providing thesupplemented feed. An extracted mineral element composition may besprayed onto a processed animal feed product, including chips orpellets, at any point in the production cycle for feed material. Anextracted mineral element composition may be sprayed onto feed once itis provided to the animals, and may be provided continuously orintermittently. An extracted mineral element composition may be providedalong side the feed, and not incorporated or added directly to the feed,and may be provided in dry or liquid form, or may be admixed orincorporated with other supplementation compositions provided to theanimals.

A supplemented water composition may be made by admixing a dry or aliquid form of an extracted mineral element composition with water andproviding the supplemented water composition to animals in all availablewater. Supplemented water comprising an extracted mineral elementcomposition may be provided continuously or on a schedule orintermittently as desired by the livestock producer.

The present invention comprises feed or water compositions, or separatecompositions comprising an extracted mineral element composition whereinthe concentration of the extracted mineral element composition is fromabout 0.0001% w/w to about 100% w/w of the composition. Ranges containedtherein are contemplated by the present invention and include, but arenot limited to, from about 0.0001% w/w to about 50% w/w of thecomposition; from about 0.001% w/w to about 10% w/w of the composition;from about 0.1% w/w to about 100% w/w of the composition; from about0.1% w/w to about 10% w/w of the composition; from about 1% w/w to about100% w/w of the composition; from about 1% w/w to about 20% w/w of thecomposition; from about 20% w/w to about 50% w/w of the composition;from about 50% w/w to about 100% w/w of the composition; and all amountstherein between. An extracted mineral element composition concentrationin a feed or water composition may be 0.001%, 0.01%, 0.1%, 1%, 2.5%, 5%,10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 70%, 80%, 90% or100% w/w of the composition.

A method of making a feed composition comprising an extracted mineralelement composition comprises some or all of the following steps. Apoultry feed generally consists of pellets that are usually produced byfeed mills. Ground cereal may be used as base. To that base otherconstituents such as oil and vegetable and animal proteins are added. Tothis mix, a dry powdered form of an extracted mineral elementcomposition or a liquid form of an extracted mineral element compositionis added. The dry or liquid extracted mineral element composition may beadded in an amount of about 0.001% w/w to about 50% w/w to the mixture.All the constituents are intimately mixed together in a grinding ormixing apparatus, sprayed with water or treated with steam and, atelevated temperature, extruded, i.e., pressed, through a nozzle having adiameter of from about 2 to about 15 mm. During that pressing process,the moistened material is compacted and it leaves the nozzle in the formof a relatively hard bar, which at the nozzle outlet is cut using acutting apparatus into pieces of desired length, for example from about5 to about 25 mm in length. The resulting pellets, which are still warm,dry in the air as they are transported away or are taken on a conveyorbelt through a heating chamber and dried at about from 80 to 120° C. Thefinished pellets are rod-shaped or cylindrical; they have a relativelysmooth surface and are readily pourable without crumbling or formingdust. They generally have a density of about 1.2 g/cm³.

An extracted mineral element composition may be added to the feedcomposition in the water or steam described above. Those skilled in theart can determine the amount of a dry or liquid extracted mineralelement composition to add to the feed to result in a desired finalconcentration of extracted minerals.

The pellets are allowed to cool to room temperature and are packed inpaper sacks or other suitable containers for storage or fortransportation to the end consumer. No special precautionary measuresare necessary because the pellets are generally storage-stable.

An extracted mineral element composition can be simply admixed withnormal dry or wet poultry food or drinking water in amounts to yield thedesired concentration of extracted minerals.

An extracted mineral element composition of the present invention andmethods for making and using such an extracted mineral elementcomposition are taught in U.S. patent application Ser. Nos. 10/752,729;11/472,536; 11/638,311; 12/499,745; 12/497,387; and 12/249,798, and incontinuation and divisional applications thereof, each of which isherein incorporated by reference in its entirety.

In general, an extracted mineral element composition is made by thefollowing methods. The extraction techniques described herein relates inpart to specific soils and soil combination compositions havingtaxonomic classifications including clay soil, sandy soil, and/orclay-sand soil comprising a combination of clay soil and sandy soil.Sandy soil typically is described as silicates. Soils classified as claysoils contain a significant percentage of clay in their composition,typically at least twenty percent by weight. A starting soil compositionmay comprise leonardite, or leonardite in combination with other soiltypes.

Soil includes very coarse, coarse, fine, very fine, and medium sizeparticle sizes. The coarse particles range in size from 0.5-1.0 mm. Thefine particles are from about 0.10-0.25 mm in size. The medium particlesare from 0.25-0.50 mm in size. Very coarse particles are greater thanabout 1.0 mm in size. The very fine particles are less than about 0.10mm in size.

The percent sand in clay-sand soil typically by definition equals or isgreater than 20% by weight. The percent of silt in clay-sand soiltypically by definition equals or is greater than 20% by weight.

Two samples of selected soil were analyzed by A&L laboratories inMemphis, Tenn. with the following results:

Soil Sample Classification Site % Clay % Sand % Silt # 4 22.5 36.5 40.9# 5 23.1 24.4 52.5

The soils from Sites 4 and/or 5 or other sites were collected andsubjected to the aqueous extraction process described below to produceboth a liquid extracted mineral element composition containing mineralelements and to produce a dry powder extracted mineral elementcomposition. The dry powder extracted mineral element composition isproduced by drying the liquid mineral element composition.

Both the liquid extracted mineral element composition and the dry powderextracted mineral element composition capture and recover similarmineral elements to constitute an extracted mineral element composition.In an aspect, both liquid and dry powder extracted mineral elementcompositions produced by the procedures described in the referencedpatent applications preferably, but not necessarily, comprise a minimumof 8 macro mineral elements and a minimum of 60 micro mineral elements.In an aspect, both liquid and dry powder extracted mineral elementcompositions produced by the procedures described in the referencedpatent applications preferably, but not necessarily, consist of aminimum 8 macro mineral elements and a minimum of 60 micro mineralelements. In an aspect, both liquid and dry powder extracted mineralelement compositions produced by the procedures described in thereferenced patent applications preferably, but not necessarily, consistessentially of minimum of 8 macro mineral elements and at least aminimum 60 micro mineral elements.

Physical testing and analysis was also conducted on the liquid and dryextracted mineral element compositions. Typical specifications of liquidextract solution range in color but preferably are from yellow to amberbrown and contain between 1-10% by weight of mineral elements, mostpreferably 3-5%. The solution is acidic with a pH ranging from 2.5-4.5,most preferably from 2.5-3.5. The liquid extract can be dried to producean anhydrous powder. The anhydrous powder presently ranges in color fromlight-off-white to brown, but preferably from yellow to golden amber, isinsoluble in any non-polar solvent such as hydrophobic liquids (oil andfats), is insoluble in alcohol, and is readily soluble, yetnon-swelling, in water and hydro-alcoholic solutions at concentrationsof 1-5%, most preferably at concentrations of 3-5% by weight. The drypowder extracted mineral element composition is partially soluble orcapable of being partially suspended in polar solvent in supersaturatedsolutions. The dry powder can also be easily suspended in non-polarsolvents.

Both liquid and dry extracted mineral element compositions produced bythe procedures described in the referenced patent applications maycomprise a minimum of 8 macro mineral elements and a minimum of 60 micromineral elements, wherein the micro mineral elements include trace andrare earth mineral elements. Both liquid and dry extracted mineralelement compositions produced by the procedures described in thereferenced patent applications may consist of a minimum of 8 macromineral elements and a minimum of 60 micro mineral elements, wherein themicro mineral elements include trace and rare earth mineral elements.Both liquid and dry extracted mineral element compositions produced bythe procedures described in the referenced patent applications mayconsist essentially of a minimum of 8 macro mineral elements and aminimum of 60 micro mineral elements, wherein the micro mineral elementsinclude trace and rare earth mineral elements.

For example, in an aspect, the dry extracted mineral element compositionmay comprise the macro mineral elements of calcium, chlorine, magnesium,manganese, phosphorous, potassium, silicon, and sodium, atconcentrations ranging from 0.0001-20.00% by weight, most preferablyfrom 0.001%-10% by weight, and, may comprise at least sixty micromineral elements at concentrations ranging from 0.00001-3.0% by weight,most preferably from 0.0001-1% by weight. The micro mineral elementsinclude aluminum, antimony, arsenic, barium, beryllium, bismuth, boron,bromine, cadmium, cerium, cesium, chromium, cobalt, copper, dysprosium,erbium, europium, fluorine, gadolinium, gold, hafnium, holmium, iodine,indium, iridium, iron, lanthanum, lead, lithium, lutetium, mercury,molybdenum, neodymium, nickel, niobium, palladium, platinum,praseodymium, rhenium, rhodium, rubidium, ruthenium, samarium, scandium,selenium, silver, strontium, sulfur, tantalum, terbium, tellurium,thallium, thorium, thulium, tin, titanium, tungsten, vanadium,ytterbium, yttrium, zinc, and zirconium.

In an aspect, the dry extracted mineral element composition may consistof the macro mineral elements of calcium, chlorine, magnesium,manganese, phosphorous, potassium, silicon, and sodium, atconcentrations ranging from 0.0001-20.00% by weight, most preferablyfrom 0.001%-10% by weight, and, may consist of at least sixty micromineral elements at concentrations ranging from 0.00001-3.0% by weight,most preferably from 0.0001-1% by weight. The micro mineral elementsinclude aluminum, antimony, arsenic, barium, beryllium, bismuth, boron,bromine, cadmium, cerium, cesium, chromium, cobalt, copper, dysprosium,erbium, europium, fluorine, gadolinium, gold, hafnium, holmium, iodine,indium, iridium, iron, lanthanum, lead, lithium, lutetium, mercury,molybdenum, neodymium, nickel, niobium, palladium, platinum,praseodymium, rhenium, rhodium, rubidium, ruthenium, samarium, scandium,selenium, silver, strontium, sulfur, tantalum, terbium, tellurium,thallium, thorium, thulium, tin, titanium, tungsten, vanadium,ytterbium, yttrium, zinc, and zirconium.

In an aspect, the dry extracted mineral element composition may consistessentially of the macro mineral elements of calcium, chlorine,magnesium, manganese, phosphorous, potassium, silicon, and sodium, atconcentrations ranging from 0.0001-20.00% by weight, most preferablyfrom 0.001%-10% by weight, and, may consist essentially of at leastsixty micro mineral elements at concentrations ranging from 0.00001-3.0%by weight, most preferably from 0.0001-1% by weight. The micro mineralelements include aluminum, antimony, arsenic, barium, beryllium,bismuth, boron, bromine, cadmium, cerium, cesium, chromium, cobalt,copper, dysprosium, erbium, europium, fluorine, gadolinium, gold,hafnium, holmium, iodine, indium, iridium, iron, lanthanum, lead,lithium, lutetium, mercury, molybdenum, neodymium, nickel, niobium,palladium, platinum, praseodymium, rhenium, rhodium, rubidium,ruthenium, samarium, scandium, selenium, silver, strontium, sulfur,tantalum, terbium, tellurium, thallium, thorium, thulium, tin, titanium,tungsten, vanadium, ytterbium, yttrium, zinc, and zirconium.

Since the process described herein normally does not introduce anyminerals as part of the extraction process, it can be established thatany minerals identified and quantified by the process described hereinhave been captured and recovered from the initial soil matter or thestarting raw material. Therefore, it can be established that theoriginal clay or other soil that processed through the extraction methoddescribed herein likely include aluminum silicates and other metalsilicates in nature which has been naturally enriched with multipledetectable minerals. It can also be established that if a mineralelement is identified and quantified in the aqueous liquid extract, itwill be identified and quantified in the dry powdered extract in muchhigher concentrations as a result of drying process or volume reduction.

For example, a lot produced using the soil and extractions methodsdescribed herein was tested by independent analytical testing forconducting chemical analysis using standard techniques of identificationand quantification for both dry and liquid forms of the comprehensivemineral composition. The results of testing performed at Teledyne WahChang Laboratories in Huntsville, Ala., utilizing scientificallyaccepted and standard equipment such as Titration, Inductively CoupledPlasma, Mass Spectrometry, and Atomic Absorption equipment resulted inthe mineral element quantification data set forth below in TABLE I foran aqueous mineral element composition and from the dry mineral elementcomposition that resulted when the aqueous mineral element compositionwas dried to produce a powder.

TABLE I Concentration of Elements in Aqueous Liquid Composition and inDry Powder Conc. in aqueous Conc. in dry Element liquid compositionpowder MACRO MINERAL ELEMENTS Calcium 2900 ppm   8% Chlorine 170 mg/ml 0.84%* Magnesium 460 ppm 0.95% Manganese 8.6 ppm  240 ppm  Phosphorous0.2 g/L 0.43% Potassium 220 mg/L  1.2% Silicon 130 mg/L 0.36% Sodium 720mg/L  2.0% MICRO MINERAL ELEMENTS Aluminum 540 ppm 0.65% Antimony 460ppb 16.0 ppm Arsenic 11 ppm  3.1 ppm Barium 340 ppb 11.0 ppm Beryllium0.29 ppm  .01 ppm Bismuth <50 ppb <1.00 ppm  Boron 2.0 mg/L 72.00 ppm Bromine *Present as part of Chlorine assay Cadmium <50 ppb 1.10 ppmTotal Organic 12 g/L Trace Carbon Cerium 1600 ppb 68.00 ppm  Cesium 82ppb 2.00 ppm Chromium 1.8 ppm 5.00 ppm Cobalt 0.25 ppm 1.00 ppm Copper0.09 ppm <1.00 ppm  Dysprosium 230 ppb 9.00 ppm Erbium 150 ppb 6.00 ppmEuropium <50 ppb 2.00 ppm Fluorine *Present as part of Chlorine assayGadolinium 220 ppb 9.00 ppm Gallium 70 ppb 2.40 ppm Germanium <50 ppb<1.00 ppm  Gold <50 ppm <1.00 ppm  Hafnium <0.5 mg/L 5.00 ppm Holmium<50 ppb 2.00 ppm Iodine *Present as part of Chlorine assay Indium <50ppb Trace Iridium <50 ppb <1.00 ppm  Iron 730 ppm 1.25% Lanthanum 650ppb 28.00 ppm  Lead <50 ppb <1.00 ppm  Lithium 0.9 mg/L <1.00 ppm Lutetium <50 ppb <1.00 ppm  Mercury Trace <1.00 ppm  Molybdenum 3200 ppb120.00 ppm  Neodymium 1000 ppb 45.00 ppm  Nickel 0.74 ppm 2.00 ppmNiobium 96 ppb 3.00 ppm Palladium <500 ppb <1.00 ppm  Platinum <50 ppb<1.00 ppm  Praseodymium 290 ppb 10.00 ppm  Rhenium <50 ppb <1.00 ppm Rhodium <50 ppb <1.00 ppm  Rubidium 360 ppb 11.00 ppm  Ruthenium <50 ppb<1.00 ppm  Samarium 250 ppb 10.00 ppm  Scandium <400 ppb 4.00 ppmSelenium 0.63 mg/L 21.00 ppm  Silver <0.02 ppm <5.00 ppm  Strontium14000 ppb 420.00 ppm  Sulfur 1.1 g/L  1.8% Tantalum <50 ppb <1.00 ppm Terbium <50 ppb 2.00 ppm Tellurium <50 ppb <1.00 ppm  Thallium <50 ppb1.00 ppm Thorium 640 ppm 22.00 ppm  Thulium <50 ppb 1.00 ppm Tin <50 ppb<1.00 ppm  Titanium 9.34 ppm 210.00 ppm  Tungsten 52 ppb 17.00 ppm Vanadium 4.3 ppm 14.00 ppm  Ytterbium 140 ppb 6.00 ppm Yttrium 1300 ppb61.00 ppm  Zinc 1.2 ppm 14.00 ppm  Zirconium 2.0 mg/L 62.00 ppm The mineral element compositions set forth above in TABLE I wereproduced from naturally occurring soil the analysis of which isreflected below in TABLE II.

TABLE II Analysis of Naturally Occurring Soil Macro Mineral ElementsConcentration in ppm by weight Element unless noted as % (for weightpercent) Silicon 25.0%  Aluminum 9.3% Potassium 4.8% Magnesium 0.83% Sulfur 1.6% Iron 1.6% Calcium 4.1% Titanium 0.23%  Sodium 0.138% Manganese 150 Gallium 25 Molybdenum 61 Germanium 25 Iodine 7 Bromine 5.2Tungsten 8.1 Hafnium 2.0 Tantalum 0.50 Zirconium 10 Arsenic 0.2 Antimony29 Selenium 4.1 Zinc 20 Samarium 3.5 Holmium 1.1 Terbium 0.62 Iridium0.51 Lutetium 0.45 Chromium 70 Lanthanum 18 Ruthenium 7.8 Yttrium 1.2Indium 0.38 Lead (under) 17 Niobium 2.89 Carbon 0.19 Hydrogen 0.05Nitrogen 0.03 Scandium 3.7 Cobalt 4.8 Ytterbium 1.4 Strontium 240 Barium390 Gold .68 Europium .49 Neodymium 20 Cerium 40 Cesium 183 ThoriumAbove 100 Uranium Above 100 Nickel 60 Beryllium 0.10 Bismuth 14.3 Boron7 Cadmium 1.12 Chloride 6100 Copper 2.2 Fluoride 3.85 Lithium 1.44Mercury 0.166 Palladium 0.74 Phosphate 320 Platinum 0.08 Rhodium 0.44Rubidium 36.5 Silver 0.3 Tellurium 0.1 Thulium 0.65 Tin 0.44 Vanadium 8Dysprosium 4.0 Praseodymium 2.0 Thallium 10 Rhenium 1.0 Erbium 2.0Oxygen 0.2

Once a desirable naturally occurring soil or soil combination isobtained, the soil(s) is subjected to the extraction process describedin U.S. patent application Ser. No. 10/725,729 (see also FIG. 11herein). The selection of an appropriate soil or soil combination is,however, important in the practice of the invention and this process isnow described. It is understood that it is possible to incorporatesynthetically produced “soils” or compositions to produce soils used inthe invention; however, the use of naturally occurring soils ispresently preferred and it is the use of such naturally occurring soilsthat is now described in detail.

Clay soils, mixtures of clay soils, or mixtures of clay soil(s) andleonardite are presently preferred in the practice of the invention. Onereason such soil combinations are preferred is that such soils can behigh in the mineral elements deemed important in the practice of theinvention. As noted, it is preferred that mineral element compositionsproduced in accordance with the invention include at least eight macromineral elements and at least sixty micro mineral elements.

The first step in determining whether a clay soil is acceptable is todetermine of arsenic, lead, mercury, and cadmium are each present inacceptably small concentrations. It is presently preferred that theconcentration of each of these elements be less than the concentrationsshown below in TABLE III.

TABLE III Maximum Desired Concentrations of Toxic Elements MaximumDesired Soil Conc. Element (ppm or ppb) Arsenic  0.2 ppm Lead  0.17 ppbMercury 0.116 ppm Cadmium  1.12 ppm

To achieve the desired concentrations noted above, a soil that has agreater than desired concentration of the toxic elements can be admixedwith one or more soils containing a lesser than desired concentration ofthe toxic elements. Further, the maximum desired concentrations of thefour toxic elements noted above can vary depending on the intended enduse of the mineral element composition produced by the invention. Forexample, if the mineral element composition is intended to be used inproducts ingested by human beings, the acceptable levels of the toxicelements normally will be less than if the mineral element compositionwill be used in agricultural products.

If the soil, or soil combination, has appropriately low concentrationsof the four toxic elements arsenic, lead, mercury, and cadmium, the soilis next tested to determine if acceptable concentrations of rare earthelements are present in the soil or soil combination. Desired levels ofrare earth elements are set forth below in TABLE IV.

TABLE IV Preferred Minimum Concentrations of Selected Rare EarthElements in Naturally Occurring Soil Preferred Minimum Element Conc. (inppm) Cerium 40 Praseodymium 2 Neodymium 20 Samarium 3.5 Europium 0.49Terbium 0.62 Dysprosium 4 Holmium 1 Erbium 2 Thulium 0.65 Ytterbium 1.2

The concentration of the elements listed in TABLE IV can vary asdesired, but, as noted, it is desirable to have at least theconcentration of each element as noted in TABLE IV. A lanthanumconcentration of at least eighteen (18) ppm and a scandium concentrationof at least three and seven-tenths (3.7) ppm are also preferred.Concentrations of promethium and gadolinium are also desirable. In thepractice of the invention, at least ten rare earth elements are presentin the soil, preferably at least twelve, and more preferably all of therare earth elements along with lanthanum and scandium. The presence ofmost or all of the rare earth elements in the soil, and in the mineralelement compositions derived from the soil, is believed to be importantin improving the efficacy of the mineral element composition wheningested by the body or when transdermally absorbed by the body.

The clay soil or soil combination also includes at least 5% by weightcalcium, preferably at least 10% by weight calcium, and most preferablyat least 20% by weight calcium. Concentrations of calcium of 25% byweight or greater are acceptable.

The clay soil or soil combination also includes at least 5% by weightsilica, preferably at least 10% by weight silica, and most preferably atleast 20% by weight silica. Concentrations of silica of 25% by weight orgreater are acceptable.

The clay soil or soil combination also includes at least 0.25% by weightphosphorous, preferably at least 1% by weight phosphorous, and mostpreferably at least 2% by weight phosphorous.

Leonardite is a valuable mineral source in producing soils that aresubjected to the extraction process illustrated in FIG. 11.

Once a clay soil or clay soil combination is obtained that contains therequisite mineral elements, the clay soil is subjected to the extractionprocess of FIG. 1 of U.S. patent application Ser. No. 10/725,729, whichis reproduced as FIG. 11 herein. The following example describes theextraction process by way of illustration, and not limitation of theinvention.

In FIG. 11 of the present application, which represents an example ofextraction process, 12,000 pounds of water purified via reverse osmosisor another desired purification process, 200 pounds of citric acid, and5000 pounds of clay soil are added to the mixing tank 10. The amount ofcitric acid (or of phosphoric acid or other edible acid(s)) used can bein the range of 0.25% to 7.5% of the weight of water utilized, buttypically is in the range of 1.0% to 2.0%. The purified water isproduced using any desired water purification technique; however, waterpurified by reverse osmosis is presently utilized. The water-citricacid-soil slurry is gently agitated (for example, with a blade slowlyrotating at from one to ten RPM) for about an hour, although theagitation time can vary as desired. The agitation is preferablynon-cavitating and is carried out without forming bubbles in themixture.

The slurry from tank 10 is directed, as indicated by arrow 16, into asettling tank 11 to permit particulate to settle downwardly out of theslurry. The slurry is maintained in the settling tank 11 for any desiredlength of time, but this length of time is presently in the range ofabout one to ten days. As the length of time that the slurry ismaintained in the settling tank 11 increases, the amount of liquid thatcan be drawn out of the tank and sent to cooling tank 12 or concentrator13 increases and the amount of solids that have settled to the bottom ofthe tank increases. Chemicals or any other desired method can beutilized to facilitate the settling of solids from slurry directed intotank 10. After the slurry has resided in settling tank 11 for thedesired period of time, liquid is drawn out of the tank to cooling tank12, or directly to the concentrator 13. The solids on the bottom of tank11 can be directed to tank 10 to be reprocessed, can be discarded, orcan be otherwise utilized.

Cooling tank 12 cools the fluid from tank 11 to a temperature in therange of forty to seventy degrees F. (5-21° C.). Tank 12 (and 14) ispresently cooled with a refrigeration system to cool the fluid in tank12. Consequently, when fluid contacts the inner cooled wall surfaces oftank 12, the wall surfaces transport heat away from and cool the fluid.Any desired system can be utilized to cool tank 12 (and 14) and/or tocool the fluid in the tank. For example, a coil can be placed in thefluid and cool the fluid without directly cooling the tank walls withrefrigeration or other system. The fluid from tank 11 is cooled toprevent or minimize yeast and mold growth. The fluid in tank 11 normallyis heated due to the ambient temperature and not due to any chemical ormechanical action that takes places in tank 11. Cooled liquid from tank12 is, as indicated by arrow 18, directed from tank 12 to concentrator13.

The concentrator 13 comprises a thin film composite reverse osmosissystem in which fluid is directed into a plurality of long, cylindrical,hollow liquid permeable membrane tubes under pressure; and, in whichfluid is forced radially out through the liquid permeable cylindricalmembrane wall to increase the concentration of the mineral elements inthe fluid. Evaporation is an alternate approach to increasing theconcentration of mineral elements in the fluid. A reverse osmosis systemis preferable to evaporation because it requires less energy, andbecause the water that passes radially through the membrane is a sourceof clean usable water.

One preferred reverse osmosis system includes eight hollow tubes or“vessels” that are about four inches in diameter and forty inches long.Each tube houses three concentric cylindrical membranes. Thepermeability flow rate is approximately 80% to 95% rejection, dependingon the feed rate and the concentration of mineral elements in the fluidbeing treated. The spacing between the three concentric membranes isabout ¼ inch. There are three ring couplers and one end plug per tube.The maximum pressure allowed by the cylindrical membranes is about 600psig. A pressure of between 300 to 450 is recommended and is normallyused. The membranes are to be utilized at a temperature of 135 degreesF. (57° C.) or less. The temperature of the fluid and the membrane is,however, typically maintained in the range of 55° F. to 65° F. (12-20°C.). The fluid from tank 11 is processed by passing it sequentiallythrough each of the eight tubes.

If desired, concentration systems other than reverse osmosis systems canbe utilized. Such other systems are not believed comparable to a reverseosmosis system in terms of cost and efficiency.

In FIG. 1 of U.S. patent application Ser. No. 10/725,729, which isreproduced herein as FIG. 11, the “slurry” by product produced by theconcentrator 13 comprises clean usable water with a low concentration ofmineral elements. The aqueous concentrate liquid produced byconcentrator 13 is, as indicated by arrow 19, directed to cooling tank14 or directly to dryer 15. Tank 14 cools the concentrate liquid to40-70° F. (5-20° C.) to prevent the growth and yeast and mold.

The concentrate liquid produced by concentrator 13 has a pH ofapproximately 3. The concentrate liquid typically includes from three totwelve percent by weight mineral elements, i.e., if the mineral elementsare separated from the concentrate liquid, a dry material is producedthat has a weight equaling about 3% to 12% by weight of the concentrateliquid. The pH of the concentrate liquid is adjusted by varying theamount of citric acid or other edible acid and/or alkaline or acidicsoil added to the mixing tank 10 and is in the range of pH 2.0 to pH5.0, preferably pH 2.5 to pH 3.5. The pH of the concentrate liquid (anddry powder or other material produced therefrom) preferably is less thanpH 4.5. TABLE I herein illustrates the mineral element present in oneconcentrate liquid produced by concentrator 13. If necessary, theconcentrate liquid is recirculated back through concentrator 13 toincrease the mineral element content in the liquid. As the proportion ofmineral elements increases, the propensity of mineral elements toprecipitate from the concentrate liquid increases. A mineral elementconcentration of at least eight percent is presently preferred forinjection into dryer 15. A mineral element concentration in the range ofthree to twelve percent or more is beneficial because many prior artprocesses currently only produce a fluid having a mineral elementconcentration of about two percent.

Any desired drying system can be utilized. The present drying apparatusconsists of a tower into which the concentrate fluid is sprayed. Air inthe tower is heated. The concentrate fluid is sprayed in a pattern thatcauses the spray to swirl down the sides of the tower. As the spraytravels down the sides of the tower, the water evaporates, producingpowder particles including mineral elements. The powder falls downwardlyto the bottom of the tower. Moist air travels upwardly through thecenter of the tower and is directed 23 to a bag house 22. The moist airenters elongate air-permeable hollow generally cylindrical bags in thebag house. The air travels outwardly through the walls of the bags andleaves behind powder particles on the inside surfaces of the bag. Thebags are shaken each thirty seconds to cause the powder on the innersurfaces of the bag to fall downwardly for collection. TABLE Iillustrates the mineral element concentration in the powder produced indryer 15 when the liquid mineral element concentrate having thecomposition set forth in TABLE I was directed into dryer 15. The drypowder mineral element composition of TABLE I in aqueous solution has apH of about 3.0.

In one spray system utilized in the dryer 15, the fluid concentrate isdirected into dryer 15 under a pressure of about 2500 psi. The orificesize of the spray nozzles utilized is about 0.027 inch. The spray angleof the nozzle is 70 degrees and the average droplet size is about 75microns.

Compositions of the present invention may comprise acceptable carriers.Compositions disclosed herein can be used in combination with anacceptable carrier. Suitable carriers and their formulations aredescribed in Remington 1995, and refers to molecular entities and otheringredients of such compositions that are physiologically tolerable anddo not typically produce untoward reactions (such as gastric upset,dizziness and the like) when administered.

As used herein, the term “carrier” applied to compositions of theinvention refers to a diluent, excipient, or vehicle with which anextracted mineral composition is administered. Such pharmaceuticalcarriers can be sterile liquids, such as water and oils, including thoseof petroleum, animal, vegetable or synthetic origin, such as peanut oil,soybean oil, mineral oil, sesame oil and the like. Water or aqueoussolution, saline solutions, and aqueous dextrose and glycerol solutionsare preferably employed as carriers, particularly for injectablesolutions. Suitable carriers are described in “Remington'sPharmaceutical Sciences” by E. W. Martin, 18th Edition.

Carriers are known to those skilled in the art. These most typicallywould be standard carriers for administration of compositions to humansor animals, including solutions such as sterile water, saline, andbuffered solutions at physiological pH. Compositions may includecarriers, thickeners, diluents, buffers, preservatives, surface activeagents and the like in addition to the extracted mineral elementcomposition. Compositions may further comprise one or more activeingredients such as antimicrobial agents, anti-inflammatory agents,anesthetics, and the like.

The composition may be administered in a number of ways depending onwhether local or systemic treatment is desired, and on the area to betreated. Administration may be topically (including ophthalmically,vaginally, rectally, intranasally), orally, by inhalation, orparenterally, for example by intravenous drip, subcutaneous,intraperitoneal or intramuscular injection. The compositions can beadministered intravenously, intraperitoneally, intramuscularly,subcutaneously, intracavity, or transdermally.

It will be understood that the embodiments of the present inventionwhich have been described are illustrative of some of the applicationsof the principles of the present invention. Numerous modifications maybe made by those skilled in the art without departing from the truespirit and scope of the invention. The term “effective” means that theamount of the composition used is of sufficient quantity to modulate,inhibit or increase, a characteristic or parameter of the subject oranimal to which an effective amount of a composition was administered orprovided. Such modulation only requires a reduction, increase oralteration, not necessarily elimination. Effective dosages and schedulesfor administering the disclosed compositions may be determinedempirically, and making such determinations is within the skill in theart. The dosage ranges for the administration of the compositions arethose large enough to produce the desired effect in the animal to whichthe composition was administered or provided. The dosage should not beso large as to cause adverse side effects. Generally, the dosage willvary with the age, condition, or sex of the animal, route ofadministration, or whether drugs are included in the regimen, and can bedetermined by one of skill in the art. Dosage can vary, and can beadministered in one or more dose administrations daily, for one orseveral days. Guidance may be found in the literature.

An effective amount of a composition comprising the extracted mineralelement composition for any particular animal will depend upon a varietyof factors including the condition and result desired from the animal,the identity and activity of the specific composition employed; the age,body weight, general health, sex and diet of the subject or animal; thetime of administration; the route of administration; the rate ofexcretion of the specific composition employed; the duration of theprovision of the composition; drugs used in combination or coincidentalwith the specific composition employed and like factors well known inthe veterinary arts.

For example, it is within the skill of the art to start doses of acomposition comprising the extracted mineral element composition atlevels lower than those required to achieve the desired effect and togradually increase the dosage until the desired effect is achieved. Onecan also evaluate the particular aspects of the animal throughtechniques such as signs, symptoms, and objective laboratory tests thatare known to be useful in evaluating the status of a animal. Forexample, if based on a comparison with an appropriate control groupand/or knowledge of the normal progression of growth or production inthe general population or the particular animal's physical condition isshown to be improved (e.g., weight is gained more rapidly), then aparticular composition dosage and regimen will be consideredefficacious. The same types of comparisons between groups or knowledgeof normal growth or production may be used for determining efficacioustreatments.

An effective amount of a disclosed composition comprising the extractedmineral element composition may be given daily, every other day, weekly,monthly, bi-monthly, every other monthly, yearly, or at any otherinterval that is determined by the caretaker or provider to beeffective. For example, an effective daily dose can be divided intomultiple doses for purposes of administration. Consequently, single dosecompositions can contain such amounts or submultiples thereof to make upthe daily dose. Disclosed compositions can also be administered as partof a combination of other administered compositions, such as feed andwater. In an aspect, disclosed compositions can be administered to thesubject prior to, subsequent to, concurrently with, or post treatmentwith other provided compositions. In an aspect, the animal receives bothadministrations on an alternating or rotating schedule. In an aspect,the animal receives a singular treatment with a disclosed composition.In an aspect, the animal receives at least one treatment with adisclosed composition. In an aspect, the animal receives at least onetreatment with a disclosed composition and at least one other treatment.

In a further aspect, an effective amount can be determined by preparinga series of compositions comprising varying amounts of disclosedcompositions such as an extracted mineral element composition anddetermining the functional or physical characteristics in vivo and invitro and matching these characteristics with specific pharmaceuticaldelivery needs, for example, subject or animal body weight or physicalcondition.

Definitions

The terminology used herein is for the purpose of describing particularaspects only and is not intended to be limiting.

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” can include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a compound”includes mixtures of compounds, reference to “a pharmaceutical carrier”includes mixtures of two or more such carriers, and the like.

Ranges may be expressed herein as from “about” one particular value,and/or to “about” another particular value. The term “about” is usedherein to mean approximately, in the region of, roughly, or around. Whenthe term “about” is used in conjunction with a numerical range, itmodifies that range by extending the boundaries above and below thenumerical values set forth. In general, the term “about” is used hereinto modify a numerical value above and below the stated value by avariance of 20%. When such a range is expressed, an aspect includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms an aspect. It will be further understood that the endpoints ofeach of the ranges are significant both in relation to the otherendpoint, and independently of the other endpoint.

The word “or” as used herein means any one member of a particular listand also includes any combination of members of that list.

“Inhibit,” “inhibiting” and “inhibition” mean to diminish or decrease anactivity, response, condition, disease, or other biological parameter.This can include, but is not limited to, the complete ablation of theactivity, response, condition, or disease. This may also include, forexample, a 10% inhibition or reduction in the activity, response,condition, or disease as compared to the native or control level. Thus,in an aspect, the inhibition or reduction can be a 10, 20, 30, 40, 50,60, 70, 80, 90, 100%, or any amount of reduction in between as comparedto native or control levels. In an aspect, the inhibition or reductionis 10-20, 20-30, 30-40, 40-50, 50-60, 60-70, 70-80, 80-90, or 90-100% ascompared to native or control levels. In an aspect, the inhibition orreduction is 0-25, 25-50, 50-75, or 75-100% as compared to native orcontrol levels.

“Modulate”, “modulating” and “modulation” as used herein mean a changein activity or function or number. The change may be an increase or adecrease, an enhancement or an inhibition of the activity, function ornumber.

“Promote,” “promotion,” and “promoting” refer to an increase in anactivity, response, condition, disease, or other biological parameter.This can include but is not limited to the initiation of the activity,response, condition, or disease. This may also include, for example, a10% increase in the activity, response, condition, or disease ascompared to the native or control level. Thus, in an aspect, theincrease or promotion can be a 10, 20, 30, 40, 50, 60, 70, 80, 90, 100%,or more, or any amount of promotion in between compared to native orcontrol levels. In an aspect, the increase or promotion is 10-20, 20-30,30-40, 40-50, 50-60, 60-70, 70-80, 80-90, or 90-100% as compared tonative or control levels. In an aspect, the increase or promotion is0-25, 25-50, 50-75, or 75-100%, or more, such as 200, 300, 500, or 1000%more as compared to native or control levels. In an aspect, the increaseor promotion can be greater than 100 percent as compared to native orcontrol levels, such as 100, 150, 200, 250, 300, 350, 400, 450, 500% ormore as compared to the native or control levels.

As used herein, the term “determining” can refer to measuring orascertaining a quantity or an amount or a change in activity. Forexample, determining the amount of a disclosed polypeptide in a sampleas used herein can refer to the steps that the skilled person would taketo measure or ascertain some quantifiable value of the polypeptide inthe sample. The art is familiar with the ways to measure an amount ofthe disclosed polypeptides and disclosed nucleotides in a sample.

The term “about” or “approximately” means within an acceptable errorrange for the particular value as determined by one of ordinary skill inthe art, which will depend in part on how the value is measured ordetermined, i.e., the limitations of the measurement system. Forexample, “about” can mean within 1 or more than 1 standard deviation,per the practice in the art. Alternatively, “about” can mean a range ofup to 20%, preferably up to 10%, more preferably up to 5%, and morepreferably still up to 1% of a given value. Alternatively, particularlywith respect to biological systems or processes, the term can meanwithin an order of magnitude, preferably within 5-fold, and morepreferably within 2-fold, of a value. Where particular values aredescribed in the application and claims, unless otherwise stated theterm “about” meaning within an acceptable error range for the particularvalue should be assumed.

“Treating” or “treatment” of a state, disorder or condition includes:(1) preventing or delaying the appearance of clinical symptoms of thestate, disorder or condition developing in an animal or bird such aspoultry (e.g., chicken) that may be afflicted with or predisposed to thestate, disorder or condition but does not yet experience or displayclinical or subclinical symptoms of the state, disorder or condition,(2) inhibiting the state, disorder or condition, i.e., arresting,reducing or delaying the development of the disease or a relapse thereof(in case of maintenance treatment) or at least one clinical orsubclinical symptom thereof, or (3) relieving the disease, i.e., causingregression of the state, disorder or condition or at least one of itsclinical or subclinical symptoms.

The benefit to animal or poultry (e.g., chicken) to be treated is eitherstatistically significant or at least perceptible the caretaker,handler, farmer, veterinarian, etc.

The present invention is not to be limited in scope by the specificembodiments described herein. Indeed, various modifications of theinvention in addition to those described herein will become apparent tothose skilled in the art from the foregoing description and theaccompanying figures. Such modifications are intended to fall within thescope of the claims.

References, including patents, patent applications, and variouspublications are cited and discussed throughout the specification. Thecitation and/or discussion of such references is provided merely toclarify the description of the present invention and is not an admissionthat any such reference is “prior art” to the present invention. Allreferences cited and discussed in this specification are eachincorporated herein by reference in its entirety and to the same extentas if each reference was individually incorporated by reference.

EXAMPLES Example 1—Egg and Chick Production

To determine the benefits of an extracted mineral element composition inprimary layers in promoting egg production and hatching efficiency,primary breeders were maintained in appropriate housing conditionsfavorable for maximum laying. The primary breeders were supplementedwith an extracted mineral element composition in liquid form via drinkwater lines at the rate of 1 ounce per gallon with continuous flow,cycled at 6 days on and 1 day off. To prevent the build up of foreignmaterial or contaminating algae or bacteria, the one off day was used toclean and flush the water lines. Layers were retired at 75 weeks of age.The breeders were kept in two barns. In Barn 1 (LH-1), 10,000 birds hada laying percentage of approximately 83.8%. In Barn 2 (LH-2), 9,200birds had a layer percentage of approximately 81.7%. The data forsixteen (16) different hatching dates is presented below.

TABLE V Summary of Data for Layers Barn #1 Barn #2 (LH-1) (LH-2) SetDate Hatch % Hatch % Jan. 3, 2010 82.0 79.1 Jan. 6, 2010 86.5 84.9 Jan.10, 2010 87.1 86.0 Jan. 17, 2010 81.5 87.7 Jan. 24, 2010 84.1 86.6 Jan.31, 2010 79.7 86.3 Feb. 3, 2010 83.3 87.8 Feb. 7, 2010 82.4 89.0 Feb.28, 2010 84.7 88.0 Mar. 7, 2010 64.6 68.9 Mar. 14, 2010 82.7 83.8 Mar.17, 2010 85.3 92.4 Mar. 21, 2010 82.6 86.6 Mar. 24, 2010 83.5 88.8 Mar.31, 2010 78.7 81.8 Apr. 4, 2010 70.2 79.2

Based on these results, the laying efficiency for 80,000 birds wascalculated. The laying efficiency per 80,000 birds laying at an averageof 85% was equal to 68,000 eggs. The average hatching percentage wascalculated from the difference between (LH-2)−(LH-1) starting at thefirst recorded hatching date (Jan. 17, 2010) through the last recordedhatching date (Apr. 4, 2010). The average hatching percentage for thecontrol group was 80.3% and the average hatching percentage for theextracted mineral element composition group was 85.2%. The increase inhatching for an extracted mineral element composition group was 4.9%.

Thus, if the laying period for the primary breeders is 57 weeks, then 57weeks×7 days per week equals 399 days. At 68,000 eggs per day, the totalnumber of eggs for the 399 days is 27,132,000. Applying this number tothe control group generates 21,786,996 chicks (i.e., 27,132,000eggs×80.3 hatching percentage). Applying this number to an extractedmineral element composition group generates 23,116,464 chicks (i.e.,27,132,100 eggs×85.2 hatching percentage). The increased difference inthe number of chicks in the extracted mineral element composition groupover the control group is 1,329,468 chicks (i.e.,23,116,464−21,786,996).

The extra earnings associated with the increase in the number of chicksgenerated by the extracted mineral element composition group was alsocalculated. The wholesale market value of a chick was calculated to be$0.37. At $0.37 per chick, the total wholesale market value of theincrease of 1,329,468 chicks in the extracted mineral elementcomposition group equals $491,903.16.

Example 2—Summary of Data from Chickens on Water or on Extracted MineralElement Composition

An extracted mineral element composition in water was provided tochickens and compared to water only (with no added extracted mineralelement composition) provided to chickens and the growth performance ofbroilers and fryers and effects on hatching efficiency of primarybreeders was examined. The study on broilers and fryers was carried outto conform to field conditions for 42 days. Similarly, primary breederswere used to evaluate an extracted mineral element composition in waterfor efficiency on percent hatching of eggs. Results after 42 daysindicated that the broilers and fryers in the group receiving anextracted mineral element composition in water were significantlyheavier than the water only group. In the primary breeder study, pulletsreceiving an extracted mineral element composition in water hadsignificantly higher hatching rates than the control group through 75weeks of age.

Quantitative data for vaccinated and non-vaccinated chickens wascompiled across several weeks. FIGS. 1A-1D show quantitative data forvaccinated and non-vaccinated chickens across several weeks. FIG. 1A(baseline through week 3) and FIG. 1B (weeks 4-7) show data fromchickens on water. FIG. 1C (baseline through week 3) and FIG. 1D (weeks4-7) show data from chickens on extracted mineral element composition inwater.

Regarding the average body weight of chickens on water or on extractedmineral element composition added to the water, the body weights ofchickens in each group increased from baseline through seven weeks.Chickens receiving an extracted mineral element composition in waterincreased more in weight during weeks 5 and 7 than chickens receivingwater only (FIG. 2).

Regarding average breast circumference of chickens on water or onextracted mineral element composition in water, breast circumference ofchickens in each group increased from baseline through seven weeks. Thebreast circumference of chickens receiving an extracted mineral elementcomposition in water increased more during weeks 1, 5, 6, and 7 thanthose of chickens receiving water only (FIG. 3).

Regarding average thigh circumference of chickens on water or anextracted mineral element composition in water, thigh circumferences ofchickens in each group increased from baseline through seven weeks.Thighs of chickens receiving an extracted mineral element composition inwater increased more in circumference during weeks 2, 3, 4, 5 and 6 thanthose of chickens receiving water only (FIG. 4).

Regarding the comparison of percent difference in body weight of chickenon water or on an extracted mineral element composition in water,increases in body weight were an average of 4% greater for chickens onan extracted mineral element composition in water during weeks 5, 6, and7 (FIG. 5).

Regarding the comparison of percent difference in breast circumferenceof chickens on water or on an extracted mineral element composition inwater, increases in breast circumference were 1-4% greater for chickenson an extracted mineral element composition in water during weeks 5, 6,and 7 (FIG. 6).

Regarding comparison of percent difference in thigh circumference ofchickens on water or on an extracted mineral element composition inwater, increases in thigh circumferences were 2-6% greater during weeks2-6 for chickens on an extracted mineral element composition in water(FIG. 7).

Regarding the average dressed weights for chickens on water or on anextracted mineral element composition in water, increases in dressedbody weights were 5.9%, 11.5%, and 14.3% greater during weeks 5, 6, and7, respectively, for chickens on an extracted mineral elementcomposition in water (FIG. 8).

Regarding mortality rate of vaccinated and non-vaccinated chickens,vaccinated chickens had a higher mortality rate. The first two weekswere the most critical for chicken survival (FIG. 9).

Regarding mortality rate of chickens on water or on an extracted mineralelement composition in water, chickens on an extracted mineral elementcomposition in water had reduced mortality rate (FIG. 10).

What is claimed:
 1. A method of increasing hatch rate of eggs fromlaying poultry, breeder poultry, or meat production poultry, comprising,a) providing a composition to laying poultry, breeder poultry, or meatproduction poultry for a particular time period in the lifespan of thepoultry, wherein the composition comprises an effective amount of anextracted mineral element composition prepared by a method consistingof: one acid treatment step, a settling step, a separating step, aconcentration step, and optionally, a drying step, wherein the one acidtreatment step consists of admixing a clay soil, a mixture of claysoils, or a mixture of clay soils and leonardite with water in an amountat least two times the weight of the soil and an acid to produce awater-acid-soil slurry, wherein the amount of acid is 0.25% to 7.5% ofthe weight of the water; wherein the settling step consists of allowingsolids from the water-acid-soil slurry to settle; wherein the separatingstep consists of separating the liquid of the water-acid-soil slurryfrom the settled solids wherein the settled solids comprisesubstantially all of the silicon and aluminum from the clay soil,mixture of clay soils, or a mixture of clay soils and leonardite;wherein the concentrating step consists of concentrating the separatedliquid to form a liquid extracted mineral element composition comprisingcalcium, chlorine, magnesium, manganese, phosphorous, potassium,silicon, and sodium, in a concentration from 0.0001% to 20.00% w/w;wherein the optional drying step consists of drying the concentratedliquid to form a dry extracted mineral element composition; and whereinfeeding laying poultry, breeder poultry, or meat production poultry theextracted mineral element composition increases egg hatch rate.
 2. Themethod of claim 1, wherein the composition is provided in feed consumedby the poultry.
 3. The method of claim 1, wherein the composition isprovided in water consumed by the poultry.
 4. The method of claim 1,wherein the composition is delivered to the poultry in capsules,powders, liquids, emulsions, oil-in-water, water-in-oil, suspensions, apoultry feed supplement, poultry feed, water compositions, or in liquidform.
 5. The method of claim 1, wherein the extracted mineral elementcomposition is in a liquid form.
 6. The method of claim 1, wherein theextracted mineral element composition is in a dry form.
 7. The method ofclaim 1, wherein the composition is provided to breeder chickens.
 8. Amethod for increasing egg fertility of eggs from laying poultry, breederpoultry, or meat production poultry, comprising, a) providing acomposition to laying poultry, breeder poultry, or meat productionpoultry for a particular time period in the lifespan of the poultry,wherein the composition comprises an effective amount of an extractedmineral element composition prepared by a method consisting of: one acidtreatment step, a settling step, a separating step, a concentrationstep, and optionally, a drying step, wherein the one acid treatment stepconsists of admixing a clay soil, a mixture of clay soils, or a mixtureof clay soils and leonardite with water in an amount at least two timesthe weight of the soil and an acid to produce a water-acid-soil slurry,wherein the amount of acid is 0.25% to 7.5% of the weight of the water;wherein the settling step consists of allowing solids from thewater-acid-soil slurry to settle; wherein the separating step consistsof separating the liquid of the water-acid-soil slurry from the settledsolids wherein the settled solids comprise substantially all of thesilicon and aluminum from the clay soil, mixture of clay soils, or amixture of clay soils and leonardite; wherein the concentrating stepconsists of concentrating the separated liquid to form a liquidextracted mineral element composition comprising calcium, chlorine,magnesium, manganese, phosphorous, potassium, silicon, and sodium, in aconcentration from 0.0001% to 20.00% w/w; wherein the optional dryingstep consists of drying the concentrated liquid to form a dry extractedmineral element composition; and wherein feeding laying poultry, breederpoultry, or meat production poultry the extracted mineral elementcomposition increases egg fertility.
 9. The method of claim 8, whereinthe composition is provided in feed consumed by the poultry.
 10. Themethod of claim 8, wherein the composition is provided in water consumedby the poultry.
 11. The method of claim 8, wherein the composition isdelivered to the poultry in capsules, powders, liquids, emulsions,oil-in-water, water-in-oil, suspensions, a poultry feed supplement,poultry feed, water compositions, or in liquid form.
 12. The method ofclaim 8, wherein the extracted mineral element composition is in aliquid form.
 13. The method of claim 8, wherein the extracted mineralelement composition is in a dry form.
 14. A method for improved eggproduction by laying poultry, breeder poultry, or meat productionpoultry, comprising, a) providing a composition to laying poultry,breeder poultry, or meat production poultry for a particular time periodin the lifespan of the poultry, wherein the composition comprises aneffective amount of an extracted mineral element composition prepared bya method consisting of: one acid treatment step, a settling step, aseparating step, a concentration step, and optionally, a drying step,wherein the one acid treatment step consists of admixing a clay soil, amixture of clay soils, or a mixture of clay soils and leonardite withwater in an amount at least two times the weight of the soil and an acidto produce a water-acid-soil slurry, wherein the amount of acid is 0.25%to 7.5% of the weight of the water; wherein the settling step consistsof allowing solids from the water-acid-soil slurry to settle; whereinthe separating step consists of separating the liquid of thewater-acid-soil slurry from the settled solids wherein the settledsolids comprise substantially all of the silicon and aluminum from theclay soil, mixture of clay soils, or a mixture of clay soils andleonardite; wherein the concentrating step consists of concentrating theseparated liquid to form a liquid extracted mineral element compositioncomprising calcium, chlorine, magnesium, manganese, phosphorous,potassium, silicon, and sodium, in a concentration from 0.0001% to20.00% w/w; wherein the optional drying step consists of drying theconcentrated liquid to form a dry extracted mineral element composition;and wherein feeding laying poultry, breeder poultry, or meat productionpoultry the extracted mineral element composition increases eggproduction and/or egg shell firmness.
 15. The method of claim 14,wherein the composition is provided in feed consumed by the poultry. 16.The method of claim 14, wherein the composition is provided in waterconsumed by the poultry.
 17. The method of claim 14, wherein thecomposition is delivered to the poultry in capsules, powders, liquids,emulsions, oil-in-water, water-in-oil, suspensions, a poultry feedsupplement, poultry feed, water compositions, or in liquid form.
 18. Themethod of claim 14, wherein the extracted mineral element composition isin a liquid form.
 19. The method of claim 14, wherein the extractedmineral element composition is in a dry form.
 20. The method of claim14, wherein the composition is provided to laying hens.